Project Manager – IVDR Technical Files & Label Cutover

Project Manager – IVDR Technical Files & Label Cutover

VARITE is looking for qualified Project Manager – IVDR Technical Files & Label Cutover in Fremont, CA.

The Project Manager will support the planning, coordination, and execution of IVDR Technical File assembly, DOC sign-off and labeling cutover projects across the Clinical Diagnostics portfolio. This role partners closely with Regulatory Affairs, Quality, R&D, Operations, Supply Chain, Labeling, and Commercial teams to ensure project milestones are achieved and regulatory commitments are met.

Key Responsibilities:

• Manage assigned IVDR Technical File and labeling projects from initiation through implementation.
• Develop and maintain project plans, timelines, action logs, risk registers, and status reports.
• Coordinate cross-functional teams to ensure project deliverables are completed on schedule.
• Track project milestones, dependencies, risks, and issues, escalating concerns as appropriate.
• Facilitate project meetings and ensure timely follow-up on action items.
• Support change management activities associated with product labeling updates and regulatory submissions.

• Partner with Regulatory Affairs, Quality Assurance, Operations, Supply Chain, Manufacturing, Marketing, and Product Management teams.
• Drive alignment on project timelines, deliverables, and implementation plans.
• Support communication of project status, risks, and key decisions to stakeholders and leadership.
• Build strong working relationships across functions to support successful execution.

• Coordinate activities related to IVDR technical documentation updates and remediation efforts.
• Support implementation of labeling changes required for IVDR compliance and product transitions.
• Track readiness activities, inventory considerations, and cutover milestones.
• Ensure project documentation is maintained in accordance with quality and regulatory requirements.
• Assist teams in identifying and mitigating risks that could impact regulatory timelines or market continuity.

Education:

• Bachelor's degree in Life Sciences, Engineering, Business, Regulatory Affairs, or a related field.

Experience:

• 3–5 years of project management, project coordination, regulatory, quality, or operations experience within the medical device, diagnostics, healthcare, or other regulated industry.
• Experience working on cross-functional projects with multiple stakeholders.
• Exposure to regulatory compliance initiatives, product lifecycle management, labeling changes, or technical documentation projects preferred.
• Experience supporting IVDR or other regulated product environments is highly desirable.

Preferred Qualifications:

• Understanding of medical device or diagnostic regulatory requirements, particularly IVDR, is a plus.

Knowledge, Skills & Abilities:

• Strong organizational and project coordination skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills.
• Effective facilitator of cross-functional meetings and discussions.
• Strong attention to detail and follow-through.
• Proficiency with Smartsheet, Excel, PowerPoint, and collaboration tools.
• Ability to identify risks and drive timely resolution with stakeholder support.
• Collaborative team player with a proactive, solution-oriented mindset.
• Comfortable working independently while escalating issues appropriately.

Benefits:

• Health Insurance:
  Medical, dental, and vision coverage
• Retirement Plans:
  Participation in a company-sponsored retirement savings plan.
• Legal Service Plans:
  Offering access to attorneys for legal advice and representation.

VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.